Classifications

• • C—CHEMISTRY; METALLURGY
  • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
  • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
  • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
  • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
  • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
  • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
• • C—CHEMISTRY; METALLURGY
  • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
  • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
  • C12Q2600/00—Oligonucleotides characterized by their use
  • C12Q2600/158—Expression markers
• • C—CHEMISTRY; METALLURGY
  • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
  • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
  • C12Q2600/00—Oligonucleotides characterized by their use
  • C12Q2600/16—Primer sets for multiplex assays

Definitions

• This disclosure relates generally to systems and methods for providing individuals with diet and exercise programs and, more specifically, relates to utilizing DNA testing for specific genes and gene variants for providing individualized diet and exercise programs based on each individual's unique genetic makeup.
• BMI Body Mass Index
• Weight management involves balancing energy intake and energy utilization, with excess energy being stored as body fat. Caloric intake beyond the body's needs and/or utilization of calories below the body's needs will lead to a net gain in weight. Excess calories may be converted to fat and stored in the body's fat cells (adipocytes) as triglycerides. Although once thought to be static in number and function from birth, adipocytes can grow in both size and number as they fill with fat and divide to form new cells.
• adipocytes fat cells
• adipose tissue increases, and adipose tissue is now recognized to be more than a collection of fat cells. Macrophages may infiltrate the tissue and secrete hormones and pro-inflammatory cytokines, which may increase an overweight individual's susceptibility to obesity and other chronic disorders, such as insulin resistance, metabolic syndrome, diabetes, heart disease, and other inflammatory conditions.
• BMI is commonly used as the measure of whether an individual is at a desirable body composition because of its convenience, but also because it is considered to be a better indicator than scale weight alone because it takes into account weight in relation to height.
• What is emerging as perhaps more insightful information, however, is the need to measure an individual's amount and location of body fat. It is stored body fat and its influence on adipose tissue secretion of pro-inflammatory cytokines that is thought to be the link between being overweight or obese and having a higher risk for developing the chronic disorders listed above. Therefore, an improved weight management algorithm is desired that is more tailored to an individual's genetic profile and how it governs their responses to macro and micro nutrients.
• a critical component in weight management is the individual's genetic makeup.
• Ancient human genes have changed little in approximately 40,000 years, yet these genes are required to interact with different environments, vastly different food supplies, more sedentary lifestyles, and exposure to a host of toxic chemicals that are metabolically active and readily stored in body fat.
• each person has the same basic set of genes (genotype) characteristic of the human species, each individual has a slightly different version of that common theme.
• Each gene is a potential source of genetic variation within the unique person's genetic makeup (genome).
• gene variants may have a positive, negative, or neutral effect on that gene's role in weight management.
• an individual's personal genotype can affect how challenging it will be for that individual to maintain a healthy weight in the environment in which they live.
• Weight management is a complex process, and genes are involved in multiple aspects of the process through the proteins they may encode. More than 100 genes have been identified as affecting the ability to maintain a healthy weight. However, no single gene has been discovered that alone is responsible for weight gain in a majority of members across multiple populations. Instead, the prevailing consensus is that there are multiple genes whose collective effect leads to increased susceptibility to weight gain and, ultimately, obesity. Further, variations in these genes do not appear to be sufficient in themselves to cause weight gain. Rather, they provide the susceptibility, but require interaction with one or more environmental factors before that susceptibility is triggered and results in weight gain. [0017] These genes and gene variants can be systematically identified based on the current understanding of the underlying metabolic mechanisms.
• variants may affect weight management outcomes by influencing such processes as the digestion, absorption, and utilization of food, particularly fat-rich food since fat is the most concentrated source of calories in the diet.
• Variants that affect any number of the metabolic processes in adipose tissue related to fat storage and mobilization should also be potential candidates.
• the invention is a method of weight management, comprising obtaining at least three, preferably 4, 5 or more, of a client's values relating to weight, height, waist circumference, hip circumference, abdominal fat, body mass index, waist-to-hip ratio, gender, and ethnicity, and the like, and detecting the presence or absence of at least 10, preferably 11 or 12 or more, genetic variants in said client, the genetic variants selected from the group consisting of rs 1047214, rsl799883, rsl800588, rsl800629, rsl800795, rsl801282, rs2070895, rs4343, rs4994, rs5082, rsl042713, rs9939609, rs2943641 or an allele linked thereto, and based on those results, selecting a suitable diet plan and an exercise plan.
• each of the detected genetic variants is assigned a Carbohydrate Score, Fat Score and Exercise Score based on the allele detected, and optionally also based on the various body measurements, gender, race and the like.
• the Carbohydrate Scores are summed, as are Fat Scores and Exercise Scores (collectively also known as nutrigenetic values and/or sums), and diet and exercise plans selected according to predetermined thresholds set for same.
• the invention relates to business methods used to provide diet and exercise and weight management services to a client.
• a method of providing weight management services includes collecting a biological sample from a client and obtaining at least three of weight, height, hip circumference, waist circumference, gender, ethnicity, and the like from said client. The presence or absence of at least 10 genetic alleles known to be associated with weight gain is then determined using said biological sample. The various results are inputted into a computer, assigning values thereto and a score computed based on same, and a weight management and exercise plan is outputted based on the scores so obtained.
• the method includes providing prepared meals or components thereof to said client that accord with the diet plan, as well as providing detailed exercise plans and/or individual coaching.
• the scores are categorized according to fat related, carbohydrate related and exercise related and separately summed and diet and exercise plans based on the three component scores.
• Yet another embodiment provides a method of providing weight management services, comprising: a) processing in a first processor a biological sample received from a client; b) receiving data representative of at least three of weight, height, hip circumference, waist circumference, gender, and ethnicity from said client; c) through the processing of the biological sample in the first processor, detecting the presence or absence of at least 10 genetic alleles known to be associated with weight gain in said biological sample; d) computing in a second processor a score based upon the processing of the biological sample and the client data received in action b); e) determining in the second processor a weight management and exercise plan based on the score obtained from action d); and f) transmitting the weight management and exercise plan to the client; and g) optionally providing through a third processor for the selection and delivery of prepared meals or components thereof to the client in accordance with the diet plan of action f).
• obtaining client sample or DNA or sequence or various data includes both direct and indirect methods of obtaining same.
• a sample can be collected at a retail center and passed on to the entity that will conduct the relevant DNA testing and such is to be included as within the scope of this term.
• sequencing any DNA or RNA includes both direct and indirect methods of obtaining sequencing information.
• the sample can be sequenced by a third party and such is to be included as within the scope of this term.
• determining any of various data includes both direct and indirect methods.
• an independent entity can do the actual genetic analysis and provide the data obtained thereby to the computer for processing in the algorithms described herein, and such is to be included within the scope of the term “determining.”
• FIGURE 1 illustrates a high level flow diagram of the genetic diet algorithm 100, in accordance with the present disclosure
• FIGURE 2 illustrates a detailed system level diagram 200 of the flow diagram of FIG. 1, in accordance with the present disclosure.
• FIGURE 3 illustrates a detailed flow diagram 300 combining the elements of FIGS. 1 and 2, in accordance with the present disclosure.
• Genes and gene variants may be evaluated on their effect on weight management and then an algorithm may be used to develop an individually tailored diet and exercise programs based on an individual's genetic makeup. Thirteen gene variants in eleven genes have currently been identified to have a sufficiently strong effect on weight management. The criteria used to evaluate whether gene variants have a sufficiently strong effect on weight include function, impact, frequency, weight management association, diet and lifestyle implications, and human intervention studies.
• the selected gene variants primarily influence the absorption of dietary fat, the storage of excess calories as body fat, or the ability to mobilize stored body fat in response to physical activity.
• 10 may provide diet-related assistance
• 5 may provide exercise-related assistance
• 2 may provide insight into both aspects of weight management.
• the relevant gene variants are listed below in TABLE 1, in relative order of contribution to weight management within their respective diet- or exercise-related categories.
• Each of the 13 gene variants in the panel may be given a "gene score” or "nutrigenetic value” which is a weighted score based on the impact of each gene variant on issues related to weight management.
• the scores are based on a scale of 0-5, with a score of 0 having no impact and a score of 5 having the greatest impact on weight loss.
• Individuals that have been genotyped may have one or more scores assigned for each gene in the panel. According to one embodiment, shown in TABLE 2 below, each individual may then receive a total Carbohydrate Score, Fat Score, and an Exercise Score based on their genetic makeup and the presence of the each of the gene variants in the panel.
• the maximum total scores for the categories are as follows: female carbohydrate score of 10, female fat score of 29, female exercise score of 16, male carbohydrate score of 9, male fat score of 28, and male exercise score of 15.
• each of the gene variants has various gene scores related to the intake of carbohydrates and fat or physical activity, although different alleles of the same gene may have different gene scores for each category, as described below.
• Gene Score of 5 The highest gene score of 5 is assigned to gene variants with multiple publications of strong associations with overweight or obese status in large populations with data from observational or intervention studies associated with intake of carbohydrates, fats, or physical activity. Additional requirements for the assignment of the gene score of 5 include: observational population based studies of greater than 5000 participants per study and intervention studies with populations of greater than 100 individuals showing a statistically significant effect on weight related parameters. Conflicting reports in the literature should be rare to nonexistent.
• Gene Score of 4 The gene score of 4 is assigned to variants with strong associations with overweight or obese status in multiple publications, but the population sizes in the publications tend to be smaller than the study sizes for gene variants assigned a gene score of 5.
• General requirements for a gene score of 4 include: observational population based studies of 500-1000 participants per study, or, alternatively, historical publications (>5) over a 5-10 year period showing similar trends with populations of approximately 100 individuals per study, and intervention studies with populations of 20-100 individuals showing a statistically significant effect on weight related parameters.
• Conflicting reports in the literature may exist, but should be relatively uncommon and related to study design or study population characteristics, such as ethnicity, age, or starting BMI, for example.
• Variants of three genes— the ACE, IRS1 and the PPARG genes— have been given a gene score of 4.
• the ACE gene may affect the exercise category parameters.
• the D allele which actually refers to the absence of an inserted Alu repeat element, has been associated with increased levels of abdominal fat, as well as other factors related to the metabolic syndrome. Individuals with the D allele respond to vigorous, power based exercise activities, hence the score of 4 for the DD genotype. Individuals with the I allele are more responsive to endurance type activities. Individuals with one copy of each allele tend to fall somewhere in the middle, hence the gene score of 3 for exercise for the ID carriers.
• the PPARG gene may affect the fat category parameters.
• the PPARG Pro 12 Ala has been associated with weight management parameters in numerous studies.
• the Pro allele has been associated with higher BMI, waist circumference, and other parameters associated with overweight and obesity, and levels of fat in the diet are particularly important for these individuals.
• IRS1 mediates the control of various cellular processes by insulin. When phosphorylated by the insulin receptor, it binds specifically to various cellular proteins containing SH2 domains, such as phosphatidylinositol 3-kinase p85 subunit or GRB2. Common genetic variants in the IRS1 gene have been recently associated with insulin resistance and hyperinsulinemia. Individuals with the IRS 1 rs2943641 CC genotype might obtain more benefits in weight loss and improvement of insulin resistance than those without this genotype by choosing a high-carbohydrate and low-fat diet.
• Gene Score of 3 The gene score of 3 is assigned to variants with consistently reported associations with overweight or obese status in multiple publications, but the population sizes in the publications tend to be smaller than those for gene scores of 4 or 5.
• General requirements for a gene score of 3 include: observational population based studies of 75-100 participants per study, or, alternatively, historical publications showing similar trends with populations of approximately 50 individuals per study, and intervention studies with populations of less than 50 individuals showing an impact on weight related parameters. Conflicting reports in the literature may exist, but should be in the minority and ideally should be related to study design and/or population composition.
• Variants of four genes—the ADRB2, PPARG, ACE, and FABP2 genes— have been given a gene score of 3.
• the ADRB2 gene may affect the fat, carbohydrate, and exercise category parameters.
• the ADRB2 Gln27Glu variant has differential effects on weight management reported in the literature dependent on gender and ethnicity.
• the gene score of 3 is assigned to females carrying the CG and GG genotypes due to repeated results demonstrating a greater impact of dietary factors, specifically carbohydrate and fat levels, as well as physical activity levels on women with these genotypes.
• Asian males demonstrate a similar, but attenuated effect relative to females, hence the gene score of 2 assigned to dietary factors for Asian males of these genotypes. There are few data on the impact of exercise in the Asian male population, so a score of zero is given for this population due to lack of evidence.
• non- Asian males demonstrate an opposite, attenuated impact relative to females, with CC carriers showing an increased impact of carbohydrate and fat dietary factors, and CC and CG carriers showing an impact of physical activity.
• the PPARG gene may affect the carbohydrate category parameters.
• the weight status of individuals with the Ala allele has an impact on how these individuals respond to carbohydrate levels in the diet; high carbohydrate levels in the diet are more deleterious for individuals with a BMI >30.
• the relative gene score of 3 or 2 (for individuals with a BMI ⁇ 30) compared with the gene score of 4 for the PPARG fat component reflects both the levels of evidence currently available and the relative impact of the two dietary factors.
• the FABP2 gene may affect the fat category parameters.
• the FABP2 Ala54Thr variant is associated with increased BMI and body fat, together with impaired fat and carbohydrate metabolism alterations, which lead to alterations in body weight parameters such as elevated plasma lipid levels, increased triglycerides and elevated blood glucose levels.
• the gene score of 3 for Fat has been assigned to the variant due to the number of observational and intervention studies that have shown that controlling fat levels in the diet can be beneficial to these individuals.
• the carbohydrate gene score of 1 reflects the situation that observational and biochemical studies support the importance of carbohydrate for this variant, but the current levels of evidence from intervention studies are somewhat limited.
• Gene Score of 2 The gene score of 2 is assigned to variants with reported associations with overweight or obese status in multiple publications, but with limited population sizes. Alternatively, associations with factors related to weight management may be reported, such as blood glucose levels or lipid levels, but less direct information on effects on BMI or body fat may be reported. General requirements for a gene score of 2 include: observational population based studies of 25-75 participants per study, or, alternatively, historical publications showing similar trends with populations of approximately 30 individuals per study, and also intervention studies with populations of less than 20 individuals showing an impact on weight related parameters. Conflicting reports in the literature may exist, but should be in the minority and ideally should be related to study design and/or population composition. Variants of eight genes— the ADRB2, ADRB3, APOA2, LIPC, IL6, FTO, IRS1, and TNF genes— have been given gene scores of 2.
• the ADRB2 gene may affect the exercise category parameters.
• the Argl6Gly variant of the ADRB2 gene similar to the Gln27Glu variant, has been associated with weight management.
• Several studies have shown a consistent trend of a positive impact of vigorous physical activity on fat mass and waist circumference in carriers of the Arg variant, leading to the assignment of a gene score of 2.
• studies to date examining dietary factors have given an almost equal mix of positive and negative findings, so at the time of this writing, a gene score of 0 has been assigned to the Fat and Carbohydrate components.
• the ADRB3 gene may also affect the exercise category parameters. Similar to the ADRB2 Argl6Gly variant, the ADRB3 Trp64Arg variant has been associated with weight management parameters and with vigorous physical activity showing an important role in reducing body fat, resulting in a gene score of 2 for Exercise.
• the APOA2 gene may affect the fat category parameters.
• the T>C variation has been associated with lower levels of the apoA-II protein, an important component of HDL particles.
• Several studies have shown an association of the C variant with elevated BMI, and individuals with the CC genotype have shown a positive response to weight management by limiting dietary saturated fat, resulting in a gene score assignment of 2 for fat.
• the LIPC gene may affect the fat category parameters.
• the -514C>T variant of the hepatic lipase gene has been associated with reduced activity, and associated with elevated BMI and visceral adiposity.
• Several studies have shown a positive impact of dietary saturated fat levels on HDL levels. However, some studies have reported no impact, leading to a gene score of 2 for fat. There is limited evidence for the role of carbohydrates and exercise at this time for this variant, so a gene score of 0 has been assigned for these parameters.
• the IL6 gene may affect the fat category parameters.
• the -175G>C variant has been associated with decreased levels of the inflammatory cytokine IL-6 in plasma.
• the G (nonvariant) allele has been associated with greater difficulty in losing weight, and G carriers have a higher tendency to regain weight. Restricting saturated fat levels and raising polyunsaturated fat levels appear to be effective with this population, leading to the assignment of a gene score of 2 for fat. To date, there is limited evidence on the role of carbohydrates and physical activity for this gene, so a gene score of 0 has been assigned for these parameters.
• the TNF gene may affect the fat category parameters.
• TNFa is an inflammatory cytokine
• the -308G>A promoter variant which leads to higher expression of the cytokine
• a meta-analysis spanning several years has calculated an odds ratio of 1.23 for excess weight for carriers of the A allele.
• a gene score of 0 has been assigned for these parameters.
• Gene Score of 1 The gene score of 1 is assigned to variants with reported associations with factors related to weight status, such as blood glucose levels or lipid levels, in smaller populations. Alternatively, associations with factors related to weight management may be reported. General requirements for a gene score of 1 include: observational population based studies of 10-25 participants per study, or, alternatively, historical publications showing similar trends with populations of a minimum 30 individuals per study, and intervention studies with 10 or more individuals showing an impact on weight related parameters, or a single long term intervention study (longer than 1 year in duration) with a population of greater than 200 individuals may be considered for assigning the gene score of 1.
• Conflicting reports in the literature may exist, but should be in the minority and ideally should be related to study design and/or population composition.
• the algorithm disclosed herein may recommend one of the four diets to the customer as a genotype-appropriate diet based on the customer's cumulative score for the diet-related gene variants. Similarly, the disclosed algorithm may recommend either the moderate or vigorous exercise approach based on the customer's cumulative score for the exercise-related gene variants.
• one algorithm that can be used entails the summing of the C scores and summing the F scores for each SNP in Table 2 and comparing these sums to thresholds.
• Exceeding the C threshold (>5 based on the arbitrary values assigned in Table 2) results in a carbohydrate-controlled diet, exceeding the F (>18) threshold results in a fat controlled diet, and exceeding both thresholds results in a fat-and-carbohydrate-controlled diet. If neither threshold is exceeded, then a balanced diet plan is indicated.
• summing the E scores and exceeding the E (>10) threshold means that an intense level exercise plan is recommended; otherwise a moderate exercise level will suffice.
• KLF14 KRUPPEL-LIKE FACTOR 14; KLF14, aka BASIC TRANSCRIPTION ELEMENT-BINDING PROTEIN 5; BTEB5
• KLF14 KRUPPEL-LIKE FACTOR 14; KLF14, aka BASIC TRANSCRIPTION ELEMENT-BINDING PROTEIN 5; BTEB5
• BTEB5 BASIC TRANSCRIPTION ELEMENT-BINDING PROTEIN 5
• rs4731702 C>T
• other ways of mathematically obtaining an equivalent score may be devised, based on the general principles taught herein. However, the general methodology is broadly applicable even if assigned values and mathematical details may vary substantially.
• the disclosed genetic diet algorithm describes four diets that may cover the variety of effects noted concerning diet-related weight management.
• One of four diets may be assigned based on normalized values, which include: (1) fat-controlled; (2) carbohydrate-controlled; (3) fat-and-carbohydrate-controlled; and (4) balanced diets.
• Each diet may be custom-developed to the macronutrient specifications and numerous nutrition standards characteristic of healthy diets.
• the fiber content in each diet may be at least 25g/day.
• the composition of the carbohydrates in some diets may be designed to deliver diets with a low glycemic load. Proteins that are lean in fat content and a mix of animal and plant proteins may be included.
• the diet can be developed to exclude trans fats and to emphasize monounsaturated fats relative to other fats. Additionally, in each diet, minimizing omega-6 polyunsaturated fats and including omega-3 polyunsaturated fats may be emphasized.
• each diet is designed to meet the nutritional requirements for adults according to the current U.S. Dietary Reference Intake guidelines.
• the disclosed calorie levels for each diet may be appropriate for weight loss for most men and women.
• the recommended calorie levels may be based on the customer's BMI at the time the program is initiated.
• Calorie level is determined by a modified BMI/age based equation which utilizes height, weight and age. In one preferred embodiment:
• the target macronutrient composition for each diet is listed below in TABLE 3
• METs a common measure of physical activity that allows the individual flexibility in choosing among a variety of types of physical activity.
• the SNPs are profiled by designing primers based on the known sequences on either side of the SNP, PCR amplification of the region in question, and testing for a particular SNP by allele specific hybridization or sequence analysis, or in some instances by restriction enzyme analysis (e.g., where the SNP affects a restriction site) or protein analysis (e.g., where the SNP changes the sequence of a protein). Where a gene is maternally imprinted, any test for methylation status can be employed, or alternatively, both parents can be tested for alelle status.
• each of the above identified SNPS are known to be co-inherited (linked) with a number of other SNPs, and thus, detection of other alleles in the haplotype can easily substitute for a particular SNP recited herein.
• the international HapMap Project provides haplotype information at http://hapmap.ncbi.nlm.nih.gov/. Thus, when discussing testing for a particular SNP herein, it is understood that any SNP in linkage with the recited SNP is to be considered equivalent and exchangeable for the recited SNP.
• haplotype searches were performed using the HapMap browser, which shows results from the International HapMap Project: hapmap.org.
• the specific rs number of the SNPs of interest was entered into the search field, using the "HapMap Genome Browser Release #27 data source.”
• SNPs with an r2 of at least 0.8 within a 40 kbp region were included and selected as sharing a haplotype of the SNPs identified herein, and the results are shown in Table 4.
• Haplotypes vary across populations and thus, the linked SNPs will vary according to which population is studied. However, Table 4 provides some exemplary linked SNPs. Additionally, some SNPs can be omitted or replaced with other more relevant SNPs without substantially changing the invention. However, in preferred embodiments at least 8/13, 9/13, or more preferably at last 10/13 or 11/13 SNPs are typed in the method. Most preferred is the full panel of 13 or more SNPs.
• the disclosed embodiments are based on the belief that choosing dietary components and exercise approaches that complement the characteristics of the individual's unique gene variants may be helpful for individuals trying to manage their weight.
• the flow diagram 100 may begin at a website hosted by a web server 102 that a customer may log onto through his or her computer 104.
• the customer may enroll in a DNA testing program and may order a DNA test kit 106 in order to receive tailored diet and exercise programs.
• a physician of record 101 may approve the order of the DNA test kit 106 if required.
• the DNA test kit 106 may be shipped to the customer and the customer may provide a DNA sample (preferably from saliva) onto a swab in the DNA test kit 106.
• the DNA sample may be provided onto the swab from a cheek sample in an embodiment, although in other embodiments, the
• DNA sample may be provided from blood, urine, hair or other sample.
• the customer may send the DNA test kit 106 to a SNP analysis system 110 for analysis.
• the SNP analysis system 110 may result, at a high level, with thirteen different single nucleotide polymorphism ("SNP") differentials 112 a through 1, each correlating to one of the 12 gene variants that have been identified to have a sufficiently strong effect on weight management, as discussed above and identified in TABLE 1.
• SNP differential 112a may correspond to the FTO gene in TABLE 1.
• the twelve different SNP differentials 112a-l may be unique to the customer based on the analysis of the DNA test kit 106 by the SNP analysis system 110. Based on the customer's unique SNP differentials 112a-l, sums of the differentials 114 may be separated to result in a sum of carb differentials 114a, a sum of fat differentials 114b, and a sum of exercise differentials 114c. The values for each SNP differential 112a-l may be found in TABLE 2, as discussed above.
• the sum of these differentials 114a-c may be used to recommend a diet 116 to the customer as a genotype-appropriate diet based on the customer's cumulative score for the diet-related gene variants.
• the customer's unique SNP differentials 112 and the sums of the differentials 114a-c may then be used to recommend either a carb-controlled diet, a fat-controlled diet, a fat-and-carb-controlled diet, or a balanced diet 116.
• the diet 116 is broadly shown in FIG. 1 in these four categories, given the specifically measured SNP differentials 112a-l, a recommended diet can be specifically tuned for a particular customer.
• the customer or nutritional advisor may look to TABLE 3, as discussed above, to see their recommended daily calorie intake based on their gender and BMI, and then the percent of their total daily calories that should be carbohydrates, protein, and fat. For example, if a male with a BMI greater than 30 is recommended a fat-controlled diet based on his unique gene variants, the customer would be recommended a 1 ,900 daily calorie diet comprised of 55% carbohydrates, 25% proteins, and 20%> fats, as well as any more specific guidance that is indicated.
• the disclosed algorithm may recommend either a moderate or vigorous exercise approach 118 based on the customer's cumulative score for the exercise-related gene variants.
• diet and exercise data 120 may be transferred to an administration server 122.
• the administration server 122 may comprise a client database that includes BMI data and gender data based on the diet and exercise data 120.
• the administration server 122 may transfer data to a distribution server 124 in order to process customer order fulfillment.
• the order fulfillment executed and instructed by the distribution server 124 may consist of shipping food, vitamins, supplements, etc. tailored to the customer's gene variants and diet and exercise programs. The order fulfillment may then be sent to the customer's desired shipping address.
• An analysis server 108 may be working on nutritional genomics, diet formulation, and/or exercise planning and may take data from anywhere in the entire data flow 100 to conduct this research. These data may include a specific customer's SNP differentials 112a-l or their sum of differentials 114a-c, recommended diet 116 or exercise 118 programs, or the entire database of BMI and gender data in the administration server 122. Continuous modifications may be made to the system in the analysis server 108 based on customer feedback, and of course one or more servers may function in the various server roles.
• FIG. 2 a detailed system level diagram 200 of the flow diagram of FIG. 1 is shown, in accordance with the present disclosure.
• the system level diagram 200 may begin when the customer orders the DNA test, as discussed above in FIG. 1, on a customer personal computer ("PC") 202 connected to the internet, referring back to FIG. 2.
• the customer PC 202 may be connected to the internet via a modem 206, and the customer may order the DNA test kit from an online website.
• the customer may display and then print the customer report/order on a printer 204.
• the modem 206 may connect the customer PC 202 to a web server 210 via an internet connection 208.
• the web server 210 may be configured to host the online website and provide an interactive interface for the exchange of information between the customer PC 202 and an administration server 212.
• the administration server 212 may be configured to exchange data with the web server 210. Additionally, the administration server 212 may be configured to maintain a database of client shipping data and transactions.
• the administration server 212 may be configured to exchange data with one or more customer service PCs 216 via an internet connection 214.
• the administration server 212 may further be configured to exchange data with one or more warehouse PC terminals 220 via an internet connection 218.
• the administration server 212 may be configured to exchange data with a laboratory information management system ("LIMS") server 224 via an internet connection 222.
• LIMS laboratory information management system
• the LIMS server 224 may be connected to a genotyping machine and integrated microcomputer 232 via an internet or intranet connection 230.
• the LIMS server 224 operates code comprising instructions stored on a computer- readable medium.
• the genotyping machine and integrated microcomputer 232 may be configured to analyze genotypes and send genotype data to the LIMS server 224.
• the LIMS server 224 may then use this genotype data in the nutrigenetic algorithm 225.
• the LIMS server 224 may also be configured to host a client genotype database and run one or more nutrigenetic algorithms 225.
• the LIMS server 224 operates code comprising computer instructions for executing the nutrigenetic algorithms 225 stored on a computer-readable medium.
• the nutrigenetic algorithm 225 may be broken down into five layers.
• the LIMS server 224 may parse and evaluate data from the lab results and may notify lab staff if the data is unsatisfactory. The presence of each of the 13 genes in the gene panel, disclosed above in TABLE 1, may be recorded.
• the LIMS server 224 may assign carbohydrate, fat, and exercise values to the data received from the lab results. The values assigned for carbohydrate, fat, and exercise correspond to the values disclosed above in TABLE 2.
• the LIMS server 224 may sum the carbohydrate, fat, and exercise values, as disclosed above in FIG. 1 at 114a-c. Referring back to FIG.
• the LIMS server 224 may evaluate the nutrigenetic values, apply thresholds, and then assign diet, exercise, and calorie intake levels for the unique customer, as disclosed above in TABLE 3.
• the LIMS server 224 may generate a customer report, describing the recommended diet, exercise, and calorie intake levels based on the clients SNP differentials.
• the LIMS server 224 may generate reports for the research and development processes.
• the LIMS server 224 may be configured to host research and development software.
• the LIMS server 224 may also be configured to be connected to a physician of record PC 228 via an internet connection 226.
• the physician of record PC 228 allows a physician of record to view and approve customer reports.
• FIGURE 3 a detailed flow diagram 300 combining the elements of FIGS. 1 and 2 is shown, in accordance with the present disclosure.
• the detailed flow diagram 300 may begin at stage one 302 where the customer registers on an interactive website hosted by a web server 304.
• the web server 304 may assign a client number to the customer, and the customer's height, weight, age, and gender data may be collected.
• the web server 304 and an administration server 308 may share the customer data from stage one 302.
• the administration server 308 may assign an accession number, which may be a unique identifier given to a DNA or protein sequence record to allow for tracking of different versions of that sequence record and the associated sequence over time, to a swab kit.
• the administration server 308 may also maintain a customer database and exchange information with customers through the website 304.
• the administration server 308 may query a LIMS server and database 340 for customer diet and exercise type based on customer and sample accession numbers.
• the administration server 308 may also make the diet and exercise program available to the website 304, as appropriate.
• the administration server 308 may be connected to a distribution server 310 that may fulfill orders and send them to the customer.
• a DNA sample kit may be sent and received, but the step order can of course be varied and this may occur at other times.
• the administration server 308 may initiate sending a pre-numbered swab kit to a customer. The customer is instructed to follow the DNA sampling instructions and then may send the pre-numbered swab kit back to the administration server 308 for processing.
• the DNA sample may be processed and moved through the administration server 308 with the coded sample accession number.
• a SNP analysis system 316 may take in DNA sample for processing at function 318. The customer number and sample accession number may be scanned or entered into the LIMS server and database 340.
• the DNA sample may be purified and amplified.
• the SNP analysis system 316 may assay the twelve SNP differentials featured in the nutrigenetic algorithm and send the results to a LIMS server and database 340.
• the output from the function 322 may be configured as SNP call outputs 324 and may include each of the twelve SNP differentials featured in the nutrigenetic algorithm, as disclosed above in TABLE 1.
• the SNP analysis system 316 may be notified and the administration server 308 may ping the customer via the website hosted by the web server 304 and request an additional DNA sample. If the sample data is acceptable, nutrigenetic values may be assigned for carbohydrates, fat, and exercise intensity effects of the twelve SNP differentials that may be part of the main array.
• each SNP differential listed as an output value 330 may correspond to a gene in TABLE 1, where, in an embodiment, for example, SNP0001 may correspond to gene FTO.
• Each SNP differential listed as an output value 330 that corresponds to a specific gene may have a value for carbohydrates, fats, and exercise, as listed in TABLE 2. For example, in FIG.
• the output values 330 for carbohydrate, fat, and exercise, respectively may be 0, 0, and 2 for SNP0001; 0, 0, and 0 for SNP0002; 1, 0, and 1 for SNP0003; 0, 1, and 0 for SNP0004; 0, 2, and 2 for SNP0005; 0, 0, and 0 for SNP0006; 0, 0, and 0 for SNP0007; 2, 2, and 4 for SNP0008; 0, 0, and 1 for SNP0009; 0, 0, and 0 for SNP0010; 1, 0, and 0 for SNP0011; and finally 2, 2, and 0 for SNP0012.
• the carbohydrate, fat, and exercise values may be modified based on any SNPs that may not be in the main array. In addition, any results that may be out of an expected range may be detected and reported. Finally, in the second algorithm layer 332, the final carbohydrate, fat, and exercise sums may be outputted as final output values 334.
• the final output values 334 may be compared with nutrigenetic thresholds.
• the output value sums 334 may be 12 for carbohydrates, 10 for fats, and 9 for exercise, based on the SNP data output 324.
• any results that may be out of an expected range may be detected and reported.
• the algorithm layer three 336 may then output diet and exercise programs 338 tailored to the customer's carbohydrate, fat, and exercise values 334.
• the recommended diet program could be a carb-controlled diet program and the recommended exercise program could be a vigorous exercise program.
• the recommended diet and exercise programs 338 may then be sent to the LIMS server and database 340, which may be configured to maintain genetic, diet, and exercise data for each customer based on customer number.
• the LIMS server and database 340 may support queries from the administration server 308, allowing the administration server 308 to have access to diet and exercise data based on customer number.
• the administration server 308 may query by customer number the LIMS server and database 340 for diet and exercise program data for a unique customer.
• the LIMS server and database 340 may then output a customer report 344 and a physician of record report 346 and send the reports 344, 346 to the administration server 308.
• the customer report 344 may include the recommended diet and exercise programs for the customer queried by the administration server 308.
• the recommended diet program may be a carb- controlled diet and the recommended exercise program may be a vigorous exercise program.
• the physician of record report 346 may be sent to the physician of record for the customer queried by the administration server 308, and may require the physician of record to review and approve each customer report 344.
• the method can also include supplying meals or components thereof that have been created to accord with the various diet plans.
• the meals or components can also be divided into single serving portions that accord with the recommended caloric intake. Because food preferences are so variable, it may be preferable to provide meal components according to fat, protein, fiber, carbohydrate and caloric requirements that are then coded so that the client can pick ands choose the various components that combine to fit the recommended diet, and it will be easy to establish a computer based ordering system that automatically provides all options available to a client that meets their diet recommendations, but does not present choices that would be outside of the recommended plan. Alternatively, with a sufficiently efficient packaging facility, it will be possible to prepare complete single serving meals based on the selections made by the client. Thus, in this way, convenience and compliance are assured, while at the same time providing totally personal meals according to client's genetic profile and choices.
• the method can also include providing exercise facilities, coaching and/or specific, detailed exercise programs. Further, the methods can be continuous and modified as a client's weight and lifestyle change.

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